NCT06371534

A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults

A Randomized, Double-blind, Single-dose, Parallel Study to Compare the Pharmacokinetics and Safety of QL2109 and DARZALEX FASPRO® in Healthy Male Adults

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2109 with DARZALEX FASPRO® in healthy male volunteers. Participants will receive a single injection of QL2109/ DARZALEX FASPRO® Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the two groups.

Detailed description

This is a phase I, randomized, double-blind and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of single injections of QL2109 or DARZALEX FASPRO in healthy volunteers. The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL2109 or DARZALEX FASPRO® in healthy volunteers. Subjects would receive a single 1800mg#15ml# of QL2109 or DARZALEX FASPRO® injection.

Conditions

• Tumor

Interventions

Type	Name	Description
DRUG	QL2109	subcutaneous injection 3-5 min D1 (Day 1, single dose)
DRUG	DARZALEX FASPRO®	subcutaneous injection 3-5 min D1 (Day 1, single dose)

Timeline

• Start date: 2024-04-12
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2024-04-17
• Last updated: 2025-02-11

Locations

2 sites across 1 country: China